Cleared Traditional

TRAC-WRIGHT SYSTEM, MODEL TW2

K910594 · Dow Corning Wright · Cardiovascular
Sep 1991
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K910594 is an FDA 510(k) clearance for the TRAC-WRIGHT SYSTEM, MODEL TW2, a Injector And Syringe, Angiographic (Class II — Special Controls, product code DXT), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on September 23, 1991, 223 days after receiving the submission on February 12, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1650.

Submission Details

510(k) Number K910594 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1991
Decision Date September 23, 1991
Days to Decision 223 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXT — Injector And Syringe, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1650

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